Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2025-12-24 @ 2:54 PM
NCT ID:
NCT06226259
Eligibility Criteria:
Inclusion Criteria:
* Children （both male and female）age 6-12 years
* Clearly diagnosed as chronic or short-term insomnia according International classification of sleep disorders-third edition（ICSD-3）
* No hearing or vision impairment, able to follow simple instructions from clinicians or parents
* Have not participated in any drug clinical trials within 3 months at the screening point
* The child or family member has the ability to evaluate and fill in a sleep diary and operate an actigraphy
* Sign informed consent
Exclusion Criteria:
* Previously diagnosed and known to be associated with intellectual disability (IQ ≤ 70)
* Clear diagnosis of anxiety disorder in the past
* Clear diagnosis of depression
* Suffering from serious cardiopulmonary and blood system diseases, low immune function, and physical diseases
* Suffering from mental developmental disorders associated with sleep disturbance and major psychosis, including well-defined (autism spectrum disorder; Attention deficit hyperactivity disorder; Schizophrenia; Schizoaffective disorder; Bipolar disorder;Post-traumatic stress disorder; Compulsive disorder; Mental disorders caused by epilepsy etc.)
* Suffering from other disorders associated with insomnia, including well-defined diagnoses (sleep apnea, periodic limb movement disorder, restless leg syndrome and nocturnal frontal lobe epilepsy, circadian dysrhythmia sleep disorder)
* Use of drugs that affect sleep (e.g. sleeping pills, sedatives, antiasthmatics, melatonin, antihistamines)
* Suffering from allergies or allergies to milk proteins and lactose intolerance
* The researchers think that is not suitable for other conditions (for example: nearly three months in other clinical research and are taking any other intervening drugs)
* Informed consent could not be obtained
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
12 Years
Study:
NCT06226259
Study Brief:
Protocol Section:
NCT06226259